Our product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States, and Kristalose® (lactulose) for Oral Solution, a prescription laxative, Vaprisol® (conivaptan) Injection, for the treatment of hyponatremia and Omeclamox®-Pak for the treatment of H. pylori and duodenal ulcer disease, and Ethyol® (amifostine) for Injection, for the treatment of oncology patients. In early 2011, we acquired the rights to ifetroban and are developing Hepatoren® (ifetroban) Injection for the treatment of Hepatorenal Syndrome, Boxaban® (ifetroban) Oral Capsule for the treatment of Aspirin-Exacerbated Respiratory Disease, VasculanTM (ifetroban) Oral Capsule for the treatment of systemic sclerosis, and Portaban™, for the treatment of portal hypertension.
Acetadote® is an FDA-approved IV treatment that prevents or reduces liver damage resulting from acetaminophen overdose, the leading cause of drug toxicity in the U.S. We developed and introduced the product in the United States in 2004, and it is currently used in more than 3,000 U.S. hospitals. With a 3-dose, 21-hour IV infusion, Acetadote® has the shortest FDA-approved treatment regimen for acetaminophen poisoning.
Acetadote® is used in the emergency department, the intensive care unit, and hospital inpatient setting to prevent or lessen liver damage from an overdose of acetaminophen, a common ingredient in many over-the-counter and prescription medications. Though safe at recommended doses, acetaminophen can cause liver damage with excessive use. Acetadote® is promoted by Cumberland’s hospital sales force, and has become a standard of care for the treatment of acetaminophen overdose in the U.S.
Caldolor® is indicated in adults and pediatric patients six months and older for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever.
Following completion of a development program involving more than 1,400 patients, we received FDA approval for Caldolor® in June 2009. We launched the product in September of that year, and continued to introduce Caldolor® to hospitals and surgical centers across the country through our organization. During 2010, Caldolor® was stocked at a growing number of U.S. medical facilities. This was a result of a dedicated effort during the year to focus on individual hospital formulary approvals for the product. As a result, we were able to achieve approval and stocking of the product at a core group of medical facilities around the U.S. We then initiated a shift in strategy to begin driving pull-through use and corresponding sales of the product.
Kristalose® is the only branded prescription laxative product that features the established safety and efficacy of lactulose, plus the convenience of a pre-measured powder dose.
A unique, dry powder crystalline formulation of lactulose, Kristalose® is designed to enhance patient compliance in the treatment of acute and chronic constipation. It is the only prescription laxative available in pre-measured powder packets, making it easily portable. Kristalose® dissolves quickly in 4 oz. of water, offering patients a virtually tasteless, grit-free and essentially calorie-free alternative to lactulose syrups. There are no age limitations or length of use restrictions for Kristalose® and it is the only osmotic prescription laxative still sampled to physicians.
In 2009, we completed a patient preference study evaluating Kristalose® compared to similar products in liquid forms. The study, which appeared in Clinical and Experimental Gastroenterology, demonstrated that 83% of patients in the study preferred the taste, consistency and portability of Kristalose® over similar products in liquid forms. This data is highly relevant to our marketing activities for Kristalose®.
Cumberland acquired the rights to ifetroban in early 2011. Ifetroban is a pharmacological antagonist of the thromboxane A2 / prostaglandin endoperoxide receptor (TPr) and has the potential to help multiple patient populations.
Hepatoren® (ifetroban) Injection is an injectable formulation of ifetroban being developed by Cumberland to treat patients suffering from hepatorenal syndrome (HRS). Cumberland is currently enrolling patients with HRS in a Phase II study of Hepatoren®.
HRS is a life-threatening condition involving reduced liver function and progressive kidney failure for which there is currently no FDA approved pharmaceutical treatment. Approximately 450,000 patients in the United States suffer from medical conditions that make them susceptible to cirrhosis and a subset of these patients develop HRS every year.
Omeclamox®--Pak is a branded prescription product used for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease. It combines three well-known and widely prescribed medications packaged together for patient convenience: omeprazole, clarithromycin, and amoxicillin.
It is the first FDA approved triple therapy combination medication to contain omeprazole as the proton pump inhibitor, which works to decrease the amount of acid the stomach produces. clarithromycin and amoxicillin are both antibiotic agents which hinder the growth of H. pylori allowing the stomach lining to heal. With a simple-to-follow 10-day course of therapy, Omeclamox-Pak has been shown to eradicate H. pylori in up to 90% of patients.
The medications are packaged together on convenient daily dosing cards, making it simple to follow the AM/PM twice a day dosing before meals. Omeclamox-Pak is available in over 15,000 retail pharmacies nationwide and is available on many managed care plan formularies.
Vaprisol® is the first and only intravenously administered vasopressin receptor antagonist, a class of pharmaceuticals developed for the treatment of euvolemic and hypervolemic hyponatremia. Vaprisol is indicated to raise serum sodium in hospitalized patients with euvolemic and hypervolemic hyponatremia. Hyponatremia, an imbalance of serum sodium to body water, is the most common electrolyte disorder among hospitalized patients. Vaprisol is premixed and administered by IV infusion.
The symptoms of hyponatremia range from fatigue, mental confusion and abnormal gate to decreased consciousness and seizures. In severe cases coma and death may occur.
Hyponatremia may occur in a wide variety of hospitalized patients. Treatment is often in a critical care setting. Among the possible causes are stroke, head trauma, liver disease, malignancy, pulmonary failure, renal failure, drug-induced, and SIADH (Syndrome of inappropriate antidiuretic hormone secretion)
In 2011, Cumberland announced the acquisition of the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies (CET). Ifetroban is a pharmacological antagonist of the thromboxane A2 / prostaglandin endoperoxide receptor (TPr) and has the potential to help multiple patient populations.
Boxaban® (ifetroban) Oral Capsule is being developed by Cumberland to treat patients suffering from aspirin-exacerbated respiratory disease (AERD), while also generating safety information that could allow ifetroban therapy to be considered for other patient populations. Cumberland received clearance for its Investigational New Drug (IND) Application from the FDA in early 2015 to commence a Phase II study for Boxaban® in patients with AERD.
Aspirin-exacerbated respiratory disease, also known as Samter's Triad, is a respiratory disease involving chronic asthma and nasal polyposis that is worsened by aspirin or nonsteroidal anti-inflammatory drugs. Current treatment of AERD remains a challenge, as novel and effective treatment modalities are lacking for this unmet medical need. Approximately one in 20 asthmatic adults (nearly 1 million patients in the United States) suffer from AERD and the disease awareness is growing within the medical community.
In 2011, we announced the acquisition of the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies (CET). Ifetroban is a pharmacological antagonist of the thromboxane A2 / prostaglandin endoperoxide receptor (TPr) and has the potential to help multiple patient populations.
Vasculan™ (ifetroban) oral capsule is being developed by Cumberland for the treatment of systemic sclerosis (SSc), also called scleroderma. It is a rare autoimmune disorder that affects the skin and internal organs. With pulmonary disease emerging as the major cause of death in SSc patients, preclinical work indicates that ifetroban is capable of preventing cardiac fibrosis in a model of pulmonary arterial hypertension.
SSc affects 2.5 million people worldwide and does not yet have a proven curative therapy. Although several medications are used to treat the skin disease associated with SSc, there is no universally effective treatment to improve the function of affected internal organs such as the lungs, heart, and gastrointestinal tract, hence the treatment of SSc remains an unmet need.
Ethyol® (amifostine) is an FDA-approved hospital product used in the prevention of xerostomia (dry-mouth) as a side-effect of radiation treatment for head and neck cancer. It is also indicated to reduce the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.
We entered an exclusive agreement with Clinigen Group plc in 2016 to commercialize Ethyol® (amifostine) in the U.S. Under the terms of the agreement, we are responsible for all marketing, promotion, and distribution of the product in the U.S.
This is our first oncology support product and is a good complement to our portfolio of specialty pharmaceuticals.